Manager Senior Mananger - Biologics-Clinical Development and Regulatory Affairs (Individual Contributor role)

Reports To: Associate Vice President

Location: Corporate Office- Govandi East

Working Days: Monday to Saturday(2nd and 4th Saturday off, 1st,3rd and 5th Saturday operational)

Role Objective

To design, drive, and execute global Clinical Development Strategies for biosimilars targeting regulated markets. This role ensures seamless clinical study management, oversees clinical CRO partnerships, and the end-to-end authoring, review, and submission of robust regulatory dossiers (eCTD). Additionally, the role is responsible for successfully resolving Ministry of Health (MOH) queries and providing strategic Regulatory Affairs (RA) support for plant-related Quality Management Systems (QMS) to ensure complete compliance and accelerated market approvals.

Key Responsibilities:

? Biosimilar Clinical Strategy & Study Management: Formulate and execute comprehensive Clinical Development Strategies for biosimilars tailored for regulated markets (e.g., USFDA, EMA).

? Clinical Trial Administration & Oversight: Lead the drafting, finalization, and submission of Clinical Trial Applications (CTA). Oversee trial data, clinical overview development, and conduct rigorous reviews of Clinical Study Reports (CSR).

? CRO Management: Selection, evaluation and finalization of CRO partner and further overview of the CRO clinical study conduct to ensure trial execution within timelines, budget, and GCP standards.

? Dossier Authoring & eCTD Submissions:



Lead and execute dossier authoring with hands-on oversight of eCTD (Electronic Common Technical Document) submissions, ensuring high-quality module preparation.

? MOH Query Resolution: Act as the primary technical anchor for drafting, reviewing, and submitting precise, timely responses to Ministry of Health (MOH) / Regulatory Authority queries.

STAKEHOLDER INTERACTION

Type of Interaction: Internal

? Interaction with: R&D;, Medical Affairs, Plant Operations / Quality Assurance (QA), and Executive Leadership. for Collaborating on clinical study designs, execution aligning regulatory dossiers

Type of Interaction: External

? Interaction with: Global Clinical CROs, Ministry of Health (MOH) / Regulatory Authorities, and Medical Writing Vendors for Managing vendor deliverables, negotiating trial contracts, overseeing clinical study conduct, auditing CRO’s, eCTD submissions, and defending clinical strategies during MOH queries.

JOB REQUIREMENTS

Qualified Experience and Relevant Skills

? Experience: 8–15 years of core experience in Clinical Development and Regulatory Affairs within the Biopharmaceutical/Biosimilars industry, with a proven track record in regulated markets

? Skills: Proven expertise in Clinical Development Strategies, synopsis and protocol design and review, CRO evaluation, Clinical Program Management and technical dossier authoring, Technical Expertise: Proficiency in CTA filings, CSR review, eCTD submission processes, and understanding of ICH-GCP guidelines.

Academic Qualifications & Certifications

? Educational Qualification: Ph.D., M.Pharm, or MD in Pharmacology.

📌 Senior Manager - Biologics-Clinical Development and RA (Maharashtra)
🏢 USV
📍 Maharashtra